Henry Ford Health System researchers defend Hydroxychloroquine study, slam politics surrounding drug

Becker's Hospital Review ^ | 08/04/2020 | Gabrielle Masson

[SeekAndFind]

The persisting political climate has made any objective discussion about hydroxychloroquine "impossible," two Henry Ford Health System executives wrote in an open letter dated Aug. 3.

Adnan Munkarah, MD, executive vice president and chief clinical officer at the Detroit-based system, along with Steven Kalkanis, MD, senior vice president and chief academic officer for Henry Ford, penned the letter in response to comments by Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, that their study on hydroxychloroquine was "flawed."

The situation is a bellwether for the kind of tension other systems may face when their clinical research overlaps with commentary from the White House.

Four things to know:

1. Addressing friends and colleagues around the world, Dr. Munkarah and Dr. Kalkanis said the most accepted and definitive way to determine treatment efficacy is a double-blind, randomized clinical trial. But this type of study takes a long time to design, execute and analyze, so observational research is used to get as best an answer as soon as possible.

2. Observational research can never completely account for biases inherent in how physicians make different decisions to treat different patients, the leaders said. It's not unusual that results vary in different studies, and no one study should be considered on its own.

3. The Henry Ford treatment study should be considered as another important contribution to hydroxychloroquine research, Drs. Munkarah and Kalkanis wrote in a letter to the editor published in the International Journal of Infectious Diseases July 31. Based on their findings, the authors believe the drug can have a role in reducing mortality for COVID-19.

4. Scientific debate is common, and can, in part, fuel the advancement of knowledge, the leaders write. They said their only goal was to report validated findings and allow the science to speak for itself, regardless of political considerations. In light of the recent events, Drs. Munkarah and Kalkanis said they have decided to no longer comment about the topic outside of the medical community and will stay focused on their patients, community and commitment to clinical and academic integrity.

[SeekAndFind]

(WXYZ) — Doctors at Henry Ford Health System penned an opened letter on the hospital's study of hydroxychloroquine being used to treat COVID-19.

It comes just days after Dr. Anthony Fauci called the study "flawed" while testifying in front of a House subcommittee.

"As an early hotspot for the COVID-19 pandemic, we have seen and lived its devastating effects alongside our patients and families. Perhaps that’s what makes us even more determined to rally our researchers, frontline care team members and leaders together in boldness, participating in scientific research, including clinical trials, to find the safest care and most effective treatments. While feeling the same sense of urgency everyone else does to recognize a simple, single remedy for COVID-19, we need to be realistic in the time it takes to fully understand the optimal therapy or combination of therapies required of a new virus we are all trying to contain," Dr. Adnan Munkarah and Dr. Steven Kalkanis said in the letter.

On Friday, Fauci said the study, which has been touted by President Donald Trump and other Republicans, contradicts other studies that found the drug does not effectively treat COVID-19.

"That study is a flawed study, and I think anyone who examines it carefully is that it is not a randomized placebo-controlled trial.

"The most well-accepted and definitive method to determine the efficacy of a treatment is a double-blind, randomized clinical trial. However, this type of study takes a long time to design, execute and analyze," the doctors wrote.

You can read the entire letter below.

To our friends and colleagues around the country and globe:

We believe wholeheartedly that a mission statement is more than a plaque we hang on a wall, but rather an idea we embed in our hearts and minds that unifies, empowers and enables us to do what we do every day for the people of our communities.

Our mission is to improve people’s lives through excellence in the science and art of health care and healing. For more than 100 years, we have proudly pioneered clinical and scientific breakthroughs that have advanced health care here and abroad.

As an early hotspot for the COVID-19 pandemic, we have seen and lived its devastating effects alongside our patients and families. Perhaps that’s what makes us even more determined to rally our researchers, frontline care team members and leaders together in boldness, participating in scientific research, including clinical trials, to find the safest care and most effective treatments. While feeling the same sense of urgency everyone else does to recognize a simple, single remedy for COVID-19, we need to be realistic in the time it takes to fully understand the optimal therapy or combination of therapies required of a new virus we are all trying to contain.

The most well-accepted and definitive method to determine the efficacy of a treatment is a double-blind, randomized clinical trial. However, this type of study takes a long time to design, execute and analyze. Therefore, a whole scientific field exists in which scientists examine how a drug is working in the real world to get as best an answer as they can as soon as possible. These types of studies can be done much more rapidly with data that is already available, usually from medical records.

Like all observational research, these studies are very difficult to analyze and can never completely account for the biases inherent in how doctors make different decisions to treat different patients. Furthermore, it is not unusual that results from such studies vary in different populations and at different times, and no one study can ever be considered all by itself.

Our promising Henry Ford treatment study should be considered as another important contribution to the other studies of hydroxychloroquine that describes what the authors found in our patient population. We – along with all doctors and scientists – eagerly support the need for randomized clinical trials.

We also want to point out that scientific debate is a common occurrence with almost every published study. In part, this is what fuels the advancement of knowledge – challenging one another on our assumptions, conclusions and applications to get to a better place for the patients we collectively serve. You can read the original study here and the senior author’s letter to the editor here.

Unfortunately, the political climate that has persisted has made any objective discussion about this drug impossible, and we are deeply saddened by this turn of events. Our goal as scientists has solely been to report validated findings and allow the science to speak for itself, regardless of political considerations. To that end, we have made the heartfelt decision to have no further comment about this outside the medical community – staying focused on our core mission in the interest of our patients, our community, and our commitment to clinical and academic integrity.

Thank you for your support.

Sincerely,

Adnan Munkarah, M.D., Executive Vice President and Chief Clinical Officer
Steven Kalkanis, M.D., Senior Vice President and Chief Academic Officer

[SeekAndFind]

Ping as per your request

[SkyDancer]

If under 0bama, this would he hailed as the wonder drug 0bama discovered and the media would be going all weepy about it.

[Dilbert San Diego]

I never understand all this “controversy” over Hydroxychloroquine.

Like Dr. Fauci said it doesn’t work, and that they haven’t done the clinical trials and all that process needed to certify that a certain medication works for a certain illness or disease.

But then many doctors have “anecdotal” evidence that it has worked for some patients. So they have prescribed the use of HCQ for their patients.

Just because there hasn’t been the official clinical trial of a medication, doesn’t mean that it doesn’t work for some medical conditions.

And it seems to be the liberals who attack the use of HCQ. perhaps because Trump had said we should use it.

Since when is anything in the field of medical science political????

[Buckeye McFrog]

Take THAT and cram it down your unmasked piehole, Dr. Tony.

[immadashell]

Drs. Munkarah and Kalkanis said they have decided to no longer comment about the topic outside of the medical community and will stay focused on their patients, community and commitment to clinical and academic integrity.

They’ve been effectively censored.

[Presbyterian Reporter]

In case you missed it-——

https://www.youtube.com/watch?v=SwbICfJ6ePs

The Charlie Kirk Show: The BIG Hydroxychloroquine Lie, Hypnotized by Fauci & MORE W/ Dr. Simone Gold

24,600 views

•Jul 22, 2020

[Mr. Jeeves]

It’s now “The Trump Drug” and if it works, they are afraid Trump will get the credit. So it can’t be admitted that it works - even if it does.

[ProtectOurFreedom]

The smarmy Fauci at the July 31 Congressional Hearing on COVID:

Dr. Fauci: (01:11) The Henry Ford Hospital study that was published, was a non-controlled, retrospective, cohort study. That was confounded by a number of issues, including the fact that many of the people who were receiving hydroxychloroquine were also receiving corticosteroids, which we know from another study, gives a clear benefit in reducing deaths with advanced disease. So, that study is a flawed study, and I think anyone who examines it carefully, is that it is not a randomized placebo-controlled trial.

Speaker 1: (01:51) It’s still peer-reviewed.

Dr. Fauci: (01:51) It doesn’t matter. You can peer-review something that’s a bad study. But, the fact is, it is not a randomized placebo-controlled trial. The point that I think is important, because we all want to keep an open mind, any and all of the randomized placebo-controlled trials, which is the gold standard of determining if something is effective, none of them had shown any efficacy by hydroxychloroquine. Having said that, I will state, when I do see a randomized placebo-controlled trial that looks at any aspect of hydroxychloroquine, either early study, middle study, or late, if that randomized placebo-controlled trial shows efficacy, I would be the first one to admit it and to promote it. But I have not seen yet a randomized placebo-controlled trial that’s done that. And in fact, every randomized placebo-controlled trial that has looked at it, has shown no efficacy.

Yeah, your “Gold Standard” would be nice, but it takes forever to design and execute such a study. In the meantime, hundreds of thousands will die. Given what we know from all the studies conducted so far, administering a placebo would be unethical.

The Republican congressman who asked Fauci the question was horribly prepared and did not rebut the “Gold Standard” argument Fauci made. They needed Jim Jordan asking bulldog tough questions.

The Republicans should have asked Fauci about his previous support of HCQ during MERS and SARS-1.

[Wally_Kalbacken]

Since when is anything in the field of medical science political????

Since the middle ages. See for example Giordano Bruno.

Science has been corrupted for a long time.

Pure science is respected for its willingness the challenge preconceptions. Political and financial interests (maintaining grants, etc.) have been bending pure science for a long time.

[SmokingJoe]

Like Dr. Fauci said it doesn’t work, and that they haven’t done the clinical trials and all that process needed to certify that a certain medication works for a certain illness or disease.

Fauci is talk in the nonsense as usual.
Professor Harvey Risch:

RISCH: No. In fact, the FDA has a huge history of drugs going into widespread use in the medical community for decades that have not been established on the basis of randomized, controlled trials. Half of the chemotherapy drugs used in cancer were used without randomized, controlled trials. The antibiotics, amoxicillin, for example, that parents use with their children all the time, day in, day out, was never established with a randomized, controlled trial before it was used.

https://www.newsbusters.org/blogs/nb/mark-finkelstein/2020/08/03/cnn-anchor-attacks-yale-prof-who-advocates-hydroxychloroquine

[Bubba_Leroy]

There used to be this thing called the “scientific method” that involved the construction and testing of a scientific hypothesis. It has now been replaced with the “politically correct” method in which the correct results are dictated by liberal prophets and compliant governmental officials. Any studies that do not support the correct results are attacked as flawed and those conducting them are attacked as heretics and in need of re-education.

Galileo is likely turning in his grave.

[Buckeye McFrog]

And you can be sure that with the breakneck speed at which it’s being rushed to market no vaccine will have met the stringent testing standards that Dr. Fauci is demanding of the 60+ year old HCQ.

[SeekAndFind]

Thanks for the YouTube link. I’m down loading it with my converter before they take the video down.

Any material with Dr. Simone Gold is a no-no to the YouTube censors.

[sauropod]

At this point, FauXi needs to be FIRED!

I no longer trust him.

[Redwood71]

“I never understand all this “controversy” over Hydroxychloroquine.”

Fauci never said the Ford study didn’t show success. He said the way the study was done, could effect the outcome. The main issue with the study, Fauci said, is that the study was not a randomized, double-blind study — which is considered “the gold standard” in science. In other words, doctors carefully selected who received the treatment, which could skew the results.

“ anecdotal” evidence that it has worked for some patients.”

“anecdotal” evidence is evidence collected in a casual or informal manner and relying heavily or entirely on personal testimony. They are looking for a vaccine, not a crap shoot. And the drug has a history of side effects. And whose to say the people got well and the drug had nothing to do with it. A vast majority do.

“...perhaps because Trump had said we should use it.”

Trump never said to use it. He said the tests have shown promise. But not confirmed yet for C-19 with the correct tests being accomplished.

Hydroxychloroquine is in a class of medications that was first used to prevent and treat malaria. Today, it is used to treat rheumatoid arthritis, some symptoms of lupus, childhood arthritis (or juvenile idiopathic arthritis) and other autoimmune diseases.

If a doctor wishes to prescribe it for C-19, he could be putting his shingle in the wind. The FDA did revoke the emergency use of it in mid June this year. They have not cleared the drug for C-19 use and it has a history of creating heart rhythm problems and other safety issues, including blood and lymph system disorders, kidney injuries, and liver problems and failure according to the FDA.

Until they can prove it works, and with the baggage it harbors, I wouldn’t want it unless I was dying, period. But it is a cleared drug to use for other illnesses, so if a doctor wishes to proscribe it, it’s his and the patient’s gamble. Law suites to follow if it goes wrong.

rwood

[Jane Long]

Thank you!!

[Dilbert San Diego]

So what of the doctors who say they have had success using it against this virus? Are they all wrong? Do they think HCQ was what helped their patients, but they are mistaken about that?

[JCL3]

At this point, FauXi needs to be FIRED!
I no longer trust him.
___________________________________________________________

Been of that mind since I saw his face, mannerisms when questioned, and his gazing down his nose at peons like us. Never did trust him.
Then there’s his love and affection for others:
https://theconservativetreehouse.com/2020/03/20/fauci-love-letters-to-hillary-clinton-surfaces/